Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Axial length change
Study Overview
Brief Summary
The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.
Detailed Description
Myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. It is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life.
Orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. However, the efficacy decreases over time. Sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. However, there lacks evidence supporting the benefit of this treatment strategy.
The purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. Subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. Their axial length will be monitored over two years. Changes in axial length in the two groups will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 8-15 years old.
- •Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
- •Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
- •Bilateral intra-ocular pressure < 21mmHg.
- •Normal binocular and stereoscopic visual function.
- •Participants and their guardians' understanding and acceptance of random allocation of grouping.
Exclusion Criteria
- •Manifest strabismus, except for intermittent tropia.
- •Ocular or systemic diseases which may affect vision or refractive error.
- •Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
- •Other contraindications.
Arms & Interventions
Ortho-k and 0.01% atropine sequential treatment
Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
Intervention: Ortho-k lenses (Device)
Ortho-k continuous treatment
Participants will be treated with ortho-k lenses throughout, during the 2-year study period.
Intervention: Ortho-k lenses (Device)
Ortho-k and 0.01% atropine sequential treatment
Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
Intervention: 0.01% Atropine (Drug)
Outcomes
Primary Outcomes
Axial length change
Time Frame: From baseline to the end of treatment at 25 months
Axial length change (mm) is characterized as the difference between 25-month follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).
Secondary Outcomes
- Axial length change(From baseline to 3, 6, 9, 12, and 19 months.)
- Proportion of rapid myopia progression(From baseline to the end of treatment at 25 months)
- Incidence of adverse events(From baseline to 25 months.)